CN102872303A - Resina draconis application paster as well as preparation and detection methods - Google Patents
Resina draconis application paster as well as preparation and detection methods Download PDFInfo
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- CN102872303A CN102872303A CN2012104251955A CN201210425195A CN102872303A CN 102872303 A CN102872303 A CN 102872303A CN 2012104251955 A CN2012104251955 A CN 2012104251955A CN 201210425195 A CN201210425195 A CN 201210425195A CN 102872303 A CN102872303 A CN 102872303A
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- sanguis draxonis
- solution
- applying patch
- applying
- alcoholic solution
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- 238000002360 preparation method Methods 0.000 title claims abstract description 25
- 238000001514 detection method Methods 0.000 title claims abstract description 8
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 53
- 238000000034 method Methods 0.000 claims abstract description 23
- 239000000843 powder Substances 0.000 claims abstract description 5
- 239000009286 sanguis draxonis Substances 0.000 claims description 158
- 239000000243 solution Substances 0.000 claims description 82
- 230000001476 alcoholic effect Effects 0.000 claims description 48
- 239000012567 medical material Substances 0.000 claims description 42
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 38
- 206010052428 Wound Diseases 0.000 claims description 29
- 238000001035 drying Methods 0.000 claims description 22
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 21
- 229960000583 acetic acid Drugs 0.000 claims description 19
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- 239000012467 final product Substances 0.000 claims description 11
- 208000014674 injury Diseases 0.000 claims description 11
- 206010013786 Dry skin Diseases 0.000 claims description 9
- WEVYAHXRMPXWCK-UHFFFAOYSA-N acetonitrile Substances CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 claims description 9
- 238000004140 cleaning Methods 0.000 claims description 8
- 230000023597 hemostasis Effects 0.000 claims description 8
- 239000012528 membrane Substances 0.000 claims description 8
- 239000002674 ointment Substances 0.000 claims description 8
- 239000011505 plaster Substances 0.000 claims description 8
- 239000000706 filtrate Substances 0.000 claims description 6
- 239000011259 mixed solution Substances 0.000 claims description 6
- 239000004745 nonwoven fabric Substances 0.000 claims description 6
- 239000013558 reference substance Substances 0.000 claims description 6
- 238000007789 sealing Methods 0.000 claims description 6
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- 238000003756 stirring Methods 0.000 claims description 3
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- 238000005406 washing Methods 0.000 claims description 3
- 238000002474 experimental method Methods 0.000 abstract description 4
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- 230000000694 effects Effects 0.000 description 22
- 208000027418 Wounds and injury Diseases 0.000 description 21
- 230000001737 promoting effect Effects 0.000 description 17
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- 230000017531 blood circulation Effects 0.000 description 13
- 239000003814 drug Substances 0.000 description 13
- 239000000047 product Substances 0.000 description 13
- CSNNHWWHGAXBCP-UHFFFAOYSA-L Magnesium sulfate Chemical compound [Mg+2].[O-][S+2]([O-])([O-])[O-] CSNNHWWHGAXBCP-UHFFFAOYSA-L 0.000 description 10
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Abstract
The invention discloses a resina draconis application paster as well as preparation and detection methods. The resina draconis application paster is made from a medicinal material of an ethanol solution for soaking resina draconis; the ethanol solution for soaking resina draconis means 40 to 80% of ethanol solution in per 100mL is added with 10 to 50g of resina draconis raw powder; the moisture in the resina draconis application paster is less than or equal to 9%; and every square centimeter of the medicinal material is added with about 0.1mL of ethanol solution. The experiments prove that the preparation and detection methods provided by the invention are more effective on the control of the content and purity of resina draconis in the resina draconis application paster products, and the precision, stability and repeatability of the method are higher; and the quality of the products can be effectively controlled, and the stability of the product quality can be guaranteed to be uniform, thereby ensuring the safety and effectiveness of the product.
Description
Technical field
The invention belongs to field of medical technology, relate to the treatment local subcutaneous tissue and traumatic injury occurs, blood stasis is had a pain, the traumatic hemorrhage edema, the medical accessory that abscess does not close up for a long time, say more specifically a kind of promoting blood circulation to remove blood stasis that has, analgesic therapy hemostasis, the Sanguis Draxonis of expelling pus and promoting granulation effect and effect apply ointment or plaster stator and preparation and detection method.
Background technology
Sanguis Draxonis is the resin of Liliaceae Dracaena cochinchinensis, and this product is the resin that the resiniferous wood of liliaceous plant Dracaena cochinchinensis Dranaena cochinchinensis (Lour.) S.C.Chen obtains through extraction.Mainly be distributed in Yunnan Province of China and country in Southeast Asia.Main Ingredients and Appearance is lourerin B, and little have delicate fragrance, lightly seasoned little puckery.Has promoting blood circulation to remove blood stasis, analgesic therapy hemostasis, the effect of expelling pus and promoting granulation.Be applicable to traumatic injury, blood stasis is had a pain, the diseases such as traumatic hemorrhage.For many years all be to get the content of capsule or Sanguis Draxonis sheet crushing got it filled that powder applies the affected part in right amount or transfer with wine and apply the affected part with dragon's blood capsule, but existing, this usage uses inconvenience, dosage is inaccurate, and medicine comes off easily and can not guarantee lasting drug effect, also causes the waste of this valuable ingredient of Chinese medicine.In the production process of capsule and tablets and other formulations, all to add in addition a little excipient and cause the generation of the situations such as allergy because the existence of excipient can affect the treatment.Especially manyly during clinical use prepare quality by patient oneself and make people worried.In addition, Sanguis Draxonis character is dissolved in water insoluble give of ethanol and makes preparation and use brings problem.
Summary of the invention
The present invention is intended to solve the above problem that prior art exists, and discloses following technical scheme for this reason:
A kind of Sanguis Draxonis applying patch is characterized in that it is to be made by the medical material that soaks into the Sanguis Draxonis alcoholic solution; The moisture in the Sanguis Draxonis applying patch≤9% wherein; Soaking into the Sanguis Draxonis alcoholic solution refers to every 100mL 40-80% alcoholic solution and adds the former powder 10-50g of Sanguis Draxonis; Every square centimeter added the about 0.1mL of alcoholic solution when described Sanguis Draxonis applying patch used.Wherein preferred alcohol solution is 70-75%(w/w).Described medical material is high-hydroscopicity paper, gauze, non-woven fabrics, and through 5 ℃ of-60 ℃ of dryings, wherein preferred baking temperature is 50 ℃-55 ℃.It is to adopt the medical material that will soak into the Sanguis Draxonis alcoholic solution to make the Sanguis Draxonis applying patch as carrier by cold drying.Medical material plays skeleton function in product, make Sanguis Draxonis absorption be stored in (in the medical material) in the skeleton, adds during use that alcoholic solution is moistening to make medical material revert to the humidity strip state to not dripping solution for well, and usefulness is fixed on the affected part with the stator of waterproof membrane again.
The present invention further discloses the preparation method of Sanguis Draxonis applying patch, it is characterized in that being undertaken by following step:
(1) with the dissolve with ethanol solution of 10g～50g Sanguis Draxonis with 100 mL 40-80% (w/w), make the Sanguis Draxonis alcoholic solution, for subsequent use;
(2) with medical material, be cut into suitable area and shape, for subsequent use;
(3) medical material that will cut out is placed in the Sanguis Draxonis alcoholic solution and soaks into;
(4) will soak into the medical material of Sanguis Draxonis alcoholic solution through 5 ℃ of-60 ℃ of dryings;
(5) with fast tester for water content the moisture in the Sanguis Draxonis applying patch is measured the moisture in the Sanguis Draxonis applying patch≤9%;
(6) the medical material sheet that contains Sanguis Draxonis after the drying is sticked on the stator with waterproof membrane, be contained in that sealing gets final product in plastic casing or the plastic bag.
The detection method of content of Sanguis Draxonis applying patch of the present invention is characterised in that by following step and is undertaken:
(1) preparation of contrast solution:
Get Sanguis Draxonis element B reference substance and get 6mg-10 mg, accurately weighed, add the glacial acetic acid solution that volume ratio is 61:39 (the 1ml glacial acetic acid adds water 90ml)-acetonitrile mixed dissolution and make the solution that 1 ml contains 60ug, and get final product.
(2) preparation method of test solution:
Get 500 square centimeters of Sanguis Draxonis applying patchs, put in the beaker, add ethanol 200ml, soaked 5 minutes and constantly stirring, soak is transferred in the measuring bottle, respectively with ethanol 100ml washing 3 times, merge cleaning mixture, water bath method is got the residue porphyrize, crosses sieve No. 4, get 0.25g, accurately weighed, put in the 25ml measuring bottle, add the glacial acetic acid solution that volume ratio is 1:1 (the 1ml glacial acetic acid adds water 90ml)-acetonitrile mixed solution 22ml, supersound process 15 minutes, let cool, add the glacial acetic acid solution that volume ratio is 1:1 (the 1ml glacial acetic acid adds water 90ml)-acetonitrile mixed solution to scale, shake up, filter, discard just filtrate, get subsequent filtrate, and get final product;
(3) accurate reference substance solution and each 10 μ l of need testing solution of drawing of algoscopy difference, the injection liquid chromatography is measured;
(4) per 10 square centimeters of Sanguis Draxonis applying patch contains Sanguis Draxonis in lourerin B, must not be less than 0.10mg.
The present invention's employing will be soaked into the Sanguis Draxonis alcoholic solution, and (medical material that per 100 mL alcoholic solution add the former powder 10-50g) of Sanguis Draxonis is made the Sanguis Draxonis applying patch by cold drying.Medical material plays skeleton function in product, make Sanguis Draxonis absorption be stored in (in the medical material) in the skeleton, it is moistening to not dripping solution state (every square centimeter adds about 0.1 mL of alcoholic solution) to add alcoholic solution during use, make medical material revert to the humidity strip state, be fixed on the affected part with the stator with waterproof membrane again.
Applying patch of the present invention is furnished with the alcoholic solution (packed or bottled) of 40-80%, and one can be used for cleaning the affected part is conducive to docile; Two are used for soaking the Sanguis Draxonis dry tablet; Three because Sanguis Draxonis is water insoluble sticks to sometimes after sticking on the skin, can be used for cleaning skin.
The more detailed preparation method of Sanguis Draxonis applying patch of the present invention is characterized in that being undertaken by following step:
(1) with the dissolve with ethanol solution of 10g～50g Sanguis Draxonis with 100mL 40-80% (preferred 70-75%), make the Sanguis Draxonis alcoholic solution, for subsequent use;
(2) with medical material, be cut into suitable area and shape, for subsequent use;
(3) medical material that will cut out is placed in the Sanguis Draxonis alcoholic solution and soaks into;
The medical material that (4) will soak into the Sanguis Draxonis alcoholic solution is through 5 ℃ of-60 ℃ of dryings (preferred 50 ℃-55 ℃),
(5) with fast tester for water content the moisture in the Sanguis Draxonis applying patch is measured the moisture in the Sanguis Draxonis applying patch≤9%;
(6) the medical material sheet that contains Sanguis Draxonis after the drying is sticked on the stator with waterproof membrane, be contained in that sealing gets final product in plastic casing or the plastic bag;
Take out the Sanguis Draxonis applying patch when (7) being used for closed trauma and ecchymoma and edema and add the preferred 70-75% of 40-80%() alcoholic solution to moistening to state, every square centimeter adds the about 0.1mL of alcoholic solution.
Take out the Sanguis Draxonis applying patch when (8) being used for open wound and directly be applied to the affected part.
(9) drying means: can adopt the methods such as low-temperature aeration drying, microwave drying, vacuum drying.
The present invention further discloses the using method of Sanguis Draxonis applying patch:
Take out the Sanguis Draxonis applying patch when (1) being used for open wound and directly be applied to the affected part; It is characterized in that using high absorbent medical material to be used as carrier and Sanguis Draxonis, run into that can to seal the blood capillary that breaks behind blood or the water terminal, absorb excessive blood, reach the effect of rapid hemostasis.Can effectively protect wound surface, promote healing; Non-stimulated to body, avirulence, safety is good.
The alcoholic solution that taking-up Sanguis Draxonis applying patch adds 40-80% when (2) being used for closed trauma and ecchymoma and edema is to moistening to state, and every square centimeter adds the about 0.1mL of alcoholic solution.Sanguis Draxonis have dissipating blood stasis analgesia, promoting blood circulation and detumescence, effect; Ethanol energy blood vessel dilating promotes the infiltration of medicine, plays analgesic effect.Sanguis Draxonis is dissolved in the ethanol, can alleviates swelling, alleviating pain, the curative effect of raising medicine.
When Sanguis Draxonis applying patch of the present invention is produced, using the ethanol preparation Sanguis Draxonis alcoholic solution of 40-80%, soak into medical material, is for the ease of the dissolving of Sanguis Draxonis raw material and the sterilization of medical material.
When Sanguis Draxonis applying patch of the present invention is produced, will soak into the medical material of Sanguis Draxonis alcoholic solution through 5 ℃ of-60 ℃ of dryings, it is in order to guarantee that Sanguis Draxonis applying patch moisture Control is convenient to preserve and steady quality≤9% that preferred temperature is 50 ℃-55 ℃.
The Sanguis Draxonis alcoholic solution that uses during Sanguis Draxonis applying patch of the present invention is produced, medical material are all being produced through strict sterilization in the environmental condition of cleaning, environmental condition lower seal in cleaning, and prevented the infection that cause in the bacteria attack affected part through sterilization treatment, guaranteed patient's safe handling.
Sanguis Draxonis applying patch of the present invention is by clinical verification, claim again decubital ulcer to be because body part is organized long-term pressurized to the slight wound of opening and pressure ulcer, disturbance of blood circulation, the continuous ischemia anoxia occurs, local malnutrition and the soft tissue that causes festers and downright bad all has preferably therapeutic effect.
Sanguis Draxonis applying patch of the present invention adds alcoholic solution to moistening to state, and every square centimeter adds the about 0.1mL of alcoholic solution, one day three times, be used for tumbling down, collide due to skin, the muscle swelling and pain due to blood stasis of soft tissue injury appearance of slight closed trauma; Can alleviate swelling, alleviating pain, the curative effect of raising medicine; Red and swollen swollen pain good results appears in external application for curing phlebitis chemotherapy Delayed onset local subcutaneous tissue, method is simple, economic and practical.
Typical clinical case is as follows:
(1) the open wound case is selected: slight open wound case wherein abrades 20 examples, incised wound 20 examples, stabs 10 examples due to cutting, tumbling down, the collision, and this product is comprised of high-hydroscopicity medical material, Sanguis Draxonis, stator.Stator self is tightened effect when pasting, closely be laminated with wound, and in blood and tissue fluid that the absorption wound oozes out, its contained Sanguis Draxonis makes the hematoblastic rapid gathering of wound circumference and fibrinogenic formation, thereby reaches the purpose of hemostasis.Area according to open wound sticks the suitable Sanguis Draxonis applying patch of area; Stick respectively 3,5,10min throws off the Sanguis Draxonis applying patch and observes haemostatic effect.A is: blood oozes out and stops;
BFor: there is micro blood to ooze out; C is: with stick front without significant change.Wound surface through observing the slight open wounds of 50 examples stick the Sanguis Draxonis applying patch and stick the 5min anastalsis and reach 86%, and the wound surface of preferred slight open wound sticks the Sanguis Draxonis applying patch and sticks more than the 5-10min.
Slight open wound patient clinical hemostasia and healing is statistical table as a result:
(2) select case soft tissue injury 12 examples because tumbling down, collide due to slight closed trauma be soft tissue injury, patient shows as skin, muscle swelling and pain due to blood stasis, sticks the suitable Sanguis Draxonis applying patch of area according to the area of closed trauma; Sanguis Draxonis applying patch using method swelling area sticks suitable Sanguis Draxonis applying patch and adds alcoholic solution to moistening to state, and every square centimeter adds the about 0.1mL of alcoholic solution, one day three times.Stick respectively 1,3,7,14 day Sanguis Draxonis applying patch and observe clinical effectiveness.A cures: swelling pain disappears
BFor taking a turn for the better: swelling pain obviously alleviates; C is invalid: swelling pain with stick front without significant change.
Due to wound causes that mostly soft tissue injury be that local hemorrhage and inflammation ooze out, organize injured after, local vascular shrinks first rear dilatation and congestion, vascular permeability increases, moisture, electrolyte, plasma protein infiltrate interstice, cause local swelling; The traditional Chinese medical science thinks, swelling and ache after the wound is because the injury QI-blood circulation is not smooth, due to the stagnation of blood stasis.Flow of QI being obstructed is then logical, and blood is not all right then swollen.Therefore we adopt the Sanguis Draxonis applying patch have dissipating blood stasis analgesia, promoting blood circulation and detumescence, astringing to arrest bleeding, hard masses softening and resolving, effect.Ethanol energy blood vessel dilating promotes the infiltration of medicine, plays analgesic effect.Sanguis Draxonis is dissolved in the ethanol, can alleviates swelling, alleviating pain, the curative effect of raising medicine.Sanguis Draxonis adds 7 days total effective rates of ethanol external application up to 67%, 14 days total effective rates of external application are up to 91%, only 1 routine swelling pain obviously alleviates but not recovery from illness, the Sanguis Draxonis applying patch adds alcoholic solution external application for curing wound and causes that the swelling pain good results appears in the soft tissue injury local subcutaneous tissue, method is simple, economic and practical, preferred docile 7-14 days.
The soft tissue injury patient clinical is statistical table as a result:
(3) pressure ulcer claims again decubital ulcer to be because body part is organized long-term pressurized, the continuous ischemia anoxia occurs in disturbance of blood circulation, local malnutrition and the soft tissue that causes festers and downright bad, pressure ulcer is one of modal complication of clinical patients, is common in chronic disease long-term bed and critical patient.It is a difficult problem in the clinical care.Sanguis Draxonis applying patch using method sticks front cleaning down wound surface and sticks suitable Sanguis Draxonis applying patch, one day three times according to wound surface is long-pending.Patient all should avoid the wound surface pressurized, and regularly changes position, promotes the healing of pressure ulcer.Stick respectively 3-21 days Sanguis Draxonis applying patchs and observe therapeutic effect.A cures: ulcer healing, decrustation;
BProduce effects: the wound surface drying is without secretions, and ulcer surface dwindles, and the granulation tissue growth is arranged; C is effective: the wound surface exudate reduces, and ulcer surface is without expansion; D is invalid: the wound surface exudate does not reduce, the unchanged or expansion of ulcer surface.
Patients with Pressure Ulcers clinical effectiveness statistical table:
Patients with Pressure Ulcers 12 routine statistical results: stick pressure ulcer in 14 days and cure 9 places, produce effects 2 places, effective 1 place; Stick pressure ulcer in 21 days and cure 10 places, produce effects 1 place, invalid 1 place (ulcer surface is unchanged).The Sanguis Draxonis applying patch, external hemostasis, granulation promoting, sore.Have blood circulation promoting and blood stasis dispelling, collateral dredging analgesic curative effect sticks the pressure ulcer position, plays blood circulation promoting and blood stasis dispelling, astriction.Reduced oozing out of wound surface, can effectively protect wound surface simultaneously, prevented from polluting.Avoid a large amount of PDs, promote blister to absorb and wound surface incrustation healing and easy to use, have no side effect, price is low, the patient is easy to acceptance.In hospital and home care, can both use.
The present invention further proves by experiment Sanguis Draxonis applying patch and magnesium sulfate dressing sheet in the treatment venous transfusion because negligent supervision causes non-aggressive, corrosive medicine or solution to enter surrounding tissue causes and ooze out and exosmose, and causes the contrast experiment that the beneficial effect of red and swollen swollen pain appears in local subcutaneous tissue:
In venous transfusion, because negligent supervision causes non-aggressive, corrosive medicine or solution to enter surrounding tissue causes and ooze out and exosmose, cause the event that red and swollen swollen pain appears in local subcutaneous tissue and happen occasionally.Have in recent years, malignant tumor patient uses chemotherapeutic often to cause that Superficial veins in various degree is scorching, brings very large misery to patient again.Case selects the patients with cerebrovascular disease continuous transfusion more than 7 days, particularly causes subcutaneous local occur red and swollen, pain because transfusion time is long, the Sanguis Draxonis applying patch swelling position of applying ointment or plaster.
Sample 1: Sanguis Draxonis applying patch using method: with specification: 5 * 10cm Sanguis Draxonis applying patch adds alcoholic solution 5mL and makes the Sanguis Draxonis applying patch to moistening to state, one day three times.Stick respectively 1-7 days Sanguis Draxonis applying patchs and observe therapeutic effect.
Sample 2: the magnesium sulfate dressing sheet, specification: 5 * 10cm is comprised of the Adlerika and the non-woven fabrics that contain 33%.Using method: one day three times.Stick respectively 1-7 days magnesium sulfate dressing sheets and observe therapeutic effect.
A cures: local redness disappears, total pain relief, and it is normal that skin histology recovers; The B produce effects: local redness disappears, total pain relief, streak vein deliquescing, and local skin leaves pigmentation; C takes a turn for the better: redness disappears, almost without pain, and vein is streak change, touches scleroma, local skin leaves pigmentation; D is invalid: chronic pain, vein are streak change, touch scleroma, the local skin blood stasis, form ulcer, limitation of activity.
20 routine patients with cerebrovascular disease clinical effectiveness statistics
Test one group: 10 routine patients with cerebrovascular disease, the 7 days Sanguis Draxonis applying patchs of applying ointment or plaster continuously, all reach the A criterion of cure: local redness disappears, total pain relief, and it is normal that skin histology recovers;
Test two groups: 10 routine patients with cerebrovascular disease, the 7 days magnesium sulfate dressing sheets of applying ointment or plaster continuously, reach the A criterion of cure: local redness disappears, total pain relief, skin histology recovers normal case 8 examples, although reach that the local rednesses of B produce effects standard 2 example disappear, total pain relief, streak vein deliquescing, local skin leaves pigmentation.
The clinical statistics result:
(1) Sanguis Draxonis applying patch, external has blood circulation promoting and blood stasis dispelling, collateral dredging analgesic curative effect sticks the affected part particularly for long red and swollen, the pain of subcutaneous local appearance that causes of transfusion time, the Sanguis Draxonis applying patch swelling position of applying ointment or plaster, play function of promoting blood circulation to disperse blood clots, be better than the magnesium sulfate dressing sheet for the therapeutic effect that occurs the swelling and pain due to blood stasis symptom because of venous transfusion.
(2) the Sanguis Draxonis applying patch has the effect of dissipating blood stasis analgesia, promoting blood circulation and detumescence, astringing to arrest bleeding, hard masses softening and resolving, promoting tissue regeneration and ulcer healing.Ethanol energy blood vessel dilating promotes the infiltration of medicine, plays analgesic effect.Sanguis Draxonis is dissolved in the ethanol, can alleviates swelling, alleviating pain, the curative effect of raising medicine.Sanguis Draxonis adds the red and swollen swollen pain good results of ethanol external application for curing phlebitis chemotherapy Delayed onset local subcutaneous tissue appearance, method is simple, economic and practical.
The good effect that the Sanguis Draxonis applying patch preparation that the present invention sets up and the method for inspection have is:
(1) dosage that the invention provides convenient clinical use is external preparation and preparation method thereof and the method for inspection accurately.The Sanguis Draxonis that uses preparation method of the present invention to make is applied ointment or plaster and can effectively be controlled the quality of product, easy to use, permeability is strong, good absorbing, economizes on resources, and is conducive to scientific utilization and the batch production of this valuable ingredient of Chinese medicine of Sanguis Draxonis, guarantee the stable of product quality, thereby guarantee the safe and effective of product.Adopt the external application of Sanguis Draxonis applying patch at disease sites by clinical case, can reach promoting blood circulation to remove blood stasis, analgesic therapy hemostasis, the purpose of expelling pus and promoting granulation.
(2) the present invention is by more effective to the quality control of Sanguis Draxonis applying patch finished product, and method precision, stability, repeatability are all higher.Prove that by experiment preparation of the present invention and the method for inspection are more effective to the Sanguis Draxonis content in the Sanguis Draxonis applying patch finished product and control of purity, method precision, stability, repeatability are all higher.Can effectively control the quality of product, guarantee the stable and consistent of product quality, thereby guarantee the safe and effective of product.
(3) provided by the invention for traumatic injury, blood stasis is had a pain, and the Sanguis Draxonis applying patch of the diseases such as traumatic hemorrhage has promoting blood circulation to remove blood stasis in clinical use, analgesic therapy hemostasis, the effect of expelling pus and promoting granulation.Be applicable to traumatic injury, blood stasis is had a pain, the diseases such as traumatic hemorrhage.Can reduce production costs, enhance productivity.The dosage of convenient clinical use is external preparation and preparation method thereof accurately.That the Sanguis Draxonis that uses preparation method of the present invention to make is applied ointment or plaster is easy to use, permeability strong, good absorbing, economizes on resources, and is conducive to the scientific utilization of this valuable ingredient of Chinese medicine of Sanguis Draxonis.Enlarged simultaneously clinical application range.
The specific embodiment
In order to explain more fully enforcement of the present invention, provide the embodiment of following preparation and the method for inspection.These embodiments only are to explain rather than limit the scope of the invention.The present invention is described further below by typical embodiment.Used raw material Sanguis Draxonis has commercially available.
Embodiment 1
(1) with the dissolve with ethanol solution of 300g Sanguis Draxonis with 1000mL 75%, make the Sanguis Draxonis alcoholic solution, for subsequent use;
(2) with medical material, be cut into suitable area and shape, for subsequent use;
(3) medical material that will cut out (non-woven fabrics) is placed in the Sanguis Draxonis alcoholic solution and soaks into;
The medical material that (4) will soak into the Sanguis Draxonis alcoholic solution adopts the vacuum drying actuator temperature to be controlled at 50 ℃ of-55 ℃ of dryings, 30 minutes time;
(5) with fast tester for water content the moisture in the Sanguis Draxonis applying patch is measured, the moisture in the Sanguis Draxonis applying patch is 7%;
(6) the medical material sheet that contains Sanguis Draxonis after the drying is sticked on the stator with waterproof membrane, be contained in that sealing gets final product in plastic casing or the plastic bag.
Embodiment 2
(1) with the dissolve with ethanol solution of 380g Sanguis Draxonis with 1000mL 60%, make the Sanguis Draxonis alcoholic solution, for subsequent use;
(2) with medical material, be cut into suitable area and shape, for subsequent use;
(3) medical material that will cut out (non-woven fabrics) is placed in the Sanguis Draxonis alcoholic solution and soaks into;
The medical material that (4) will soak into the Sanguis Draxonis alcoholic solution adopts the vacuum drying actuator temperature to be controlled at 40 ℃ of-50 ℃ of dryings, 60 minutes time;
(5) with fast tester for water content the moisture in the Sanguis Draxonis applying patch is measured, the moisture in the Sanguis Draxonis applying patch is 8.5%;
(6) the medical material sheet that contains Sanguis Draxonis after the drying is sticked on the stator with waterproof membrane, be contained in that sealing gets final product in plastic casing or the plastic bag.
Embodiment 3
(1) with the dissolve with ethanol solution of 450g Sanguis Draxonis with 1000mL 70%, make the Sanguis Draxonis alcoholic solution, for subsequent use;
(2) with medical material, be cut into suitable area and shape, for subsequent use;
(3) medical material that will cut out (gauze) is placed in the Sanguis Draxonis alcoholic solution and soaks into;
The medical material that (4) will soak into the Sanguis Draxonis alcoholic solution adopts the aeration-drying temperature to be controlled at 30 ℃ of-45 ℃ of dryings, 120 minutes time;
(5) with fast tester for water content the moisture in the Sanguis Draxonis applying patch is measured, the moisture in the Sanguis Draxonis applying patch is 8%;
(6) the medical material sheet that contains Sanguis Draxonis after the drying is sticked on the stator with waterproof membrane, be contained in that sealing gets final product in plastic casing or the plastic bag.
Embodiment 4
The detection method of Sanguis Draxonis applying patch:
Specification is 6 * 9cm; Per 10 square centimeters contain Sanguis Draxonis in lourerin B, must not be less than 0.10mg.
(1) product structure, composition and material: the Sanguis Draxonis applying patch is comprised of Sanguis Draxonis and non-woven fabrics.
(2) outward appearance: the Sanguis Draxonis applying patch is clean and tidy on inspection, without defectives such as broken hole, stain, mildew, impurity.
(3) size: the Sanguis Draxonis applying patch is 5 on inspection, and every wide 6cm * long 9cm does not all surpass ± 10%.
(4) assay:
Get Sanguis Draxonis element B reference substance 6mg, accurately weighed, add the glacial acetic acid solution that volume ratio is 61:39 (the 1ml glacial acetic acid adds water 90ml)-acetonitrile mixed dissolution and make the solution that 1 ml contains 60ug, and get final product.
Get 500 square centimeters of Sanguis Draxonis applying patchs, put in the beaker, add ethanol 200ml, soaked 5 minutes and constantly stirring, soak is transferred in the measuring bottle, respectively with ethanol 100ml washing 3 times, merge cleaning mixture, water bath method is got the residue porphyrize, crosses sieve No. 4, get 0.25g, accurately weighed, put in the 25ml measuring bottle, add the glacial acetic acid solution that volume ratio is 1:1 (the 1ml glacial acetic acid adds water 90ml)-acetonitrile mixed solution 22ml, supersound process 15 minutes, let cool, add the glacial acetic acid solution that volume ratio is 1:1 (the 1ml glacial acetic acid adds water 90ml)-acetonitrile mixed solution to scale, shake up, filter, discard just filtrate, get subsequent filtrate, and get final product;
(5) with fast tester for water content the moisture in the Sanguis Draxonis applying patch is measured, the moisture in the Sanguis Draxonis applying patch is 6.5%.
Claims (6)
1. a Sanguis Draxonis applying patch is characterized in that it is to be made by the medical material that soaks into the Sanguis Draxonis alcoholic solution; The described Sanguis Draxonis alcoholic solution that soaks into refers to every 100mL 40-80%(w/w) alcoholic solution adds the former powder 10-50g of Sanguis Draxonis; Moisture in the Sanguis Draxonis applying patch≤9%; Per 10 square centimeters of Sanguis Draxonis applying patch contains Sanguis Draxonis in lourerin B, must not be less than 0.10mg.
2. Sanguis Draxonis applying patch claimed in claim 1, wherein alcoholic solution is 70-75%(w/w).
3. Sanguis Draxonis applying patch claimed in claim 1, medical material wherein is high-hydroscopicity paper, gauze, non-woven fabrics, through 5 ℃ of-60 ℃ of dryings.
4. the preparation method of the described Sanguis Draxonis applying patch of claim 1 is characterized in that being undertaken by following step:
(1) with the dissolve with ethanol solution of 10g～50g Sanguis Draxonis with 100 mL 40-80% (w/w), make the Sanguis Draxonis alcoholic solution, for subsequent use;
(2) with medical material, be cut into suitable area and shape, for subsequent use;
(3) medical material that will cut out is placed in the Sanguis Draxonis alcoholic solution and soaks into;
(4) will soak into the medical material of Sanguis Draxonis alcoholic solution through 5 ℃ of-60 ℃ of dryings;
(5) with fast tester for water content the moisture in the Sanguis Draxonis applying patch is measured the moisture in the Sanguis Draxonis applying patch≤9%;
(6) the medical material sheet that contains Sanguis Draxonis after the drying is sticked on the stator with waterproof membrane, be contained in that sealing namely obtains applying patch in plastic casing or the plastic bag.
5. the detection method of content of the described Sanguis Draxonis applying patch of claim 1 is characterised in that by following step and is undertaken:
(1) preparation of contrast solution:
Get Sanguis Draxonis element B reference substance and get 6mg-10 mg, accurately weighed, add volume ratio and be the glacial acetic acid solution of 61:39-acetonitrile mixed dissolution and make the solution that 1ml contains 60ug, and get final product, glacial acetic acid solution wherein refers to the 1ml glacial acetic acid and adds water 90ml;
(2) preparation method of test solution:
Get 500 square centimeters of Sanguis Draxonis applying patchs, put in the beaker, add ethanol 200ml, soaked 5 minutes and constantly stirring, soak is transferred in the measuring bottle, respectively with ethanol 100ml washing 3 times, merge cleaning mixture, water bath method is got the residue porphyrize, crosses sieve No. 4, get 0.25g, accurately weighed, put in the 25ml measuring bottle, add volume ratio and be the glacial acetic acid solution of 1:1-acetonitrile mixed solution 22ml, supersound process 15 minutes, let cool, add volume ratio and be the glacial acetic acid solution of 1:1-acetonitrile mixed solution to scale, shake up, filter, discard just filtrate, get subsequent filtrate, and get final product; Glacial acetic acid solution wherein refers to the 1ml glacial acetic acid and adds water 90ml;
(3) accurate reference substance solution and each 10 μ l of need testing solution of drawing of algoscopy difference, the injection liquid chromatography is measured;
(4) per 10 square centimeters of Sanguis Draxonis applying patch contains Sanguis Draxonis in lourerin B, must not be less than 0.10mg.
6. the described Sanguis Draxonis applying patch of claim 1 using method is characterized in that:
Taking out the Sanguis Draxonis applying patch when (1) being used for the open wound hemostasis directly applies ointment or plaster;
The alcoholic solution that taking-up Sanguis Draxonis applying patch adds 40-80% when (2) being used for closed trauma and ecchymoma and edema is to moistening to state, and every square centimeter adds alcoholic solution 0.1mL.
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| CN103191284A (en) * | 2013-03-21 | 2013-07-10 | 中国医学科学院药用植物研究所云南分所 | Dragon blood spraying film agent applied to superficial wound and preparation technology thereof |
| CN103919967A (en) * | 2014-04-03 | 2014-07-16 | 张荣平 | Dracaena cochinchinensis resin compound and application thereof in preparation of medicines for treating trauma |
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| CN103919967B (en) * | 2014-04-03 | 2016-10-05 | 张荣平 | Sanguis Draxonis compound recipe and the application in preparation treatment more wound medicine thereof |
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| CN102872303B (en) | 2014-06-25 |
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